Clinical Trial: Neuroform Atlas Stent for Intracranial Aneurysm Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Evaluation of Safety and Performance of the Neuroform AtlasTM Stent System for Intracranial Aneurysm Treatment - Post Market Clinical Follow-up

Brief Summary: The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.

Detailed Summary: The study is a prospective, multicenter, open-label, single arm post market follow-up registry designed to demonstrate the potential treatment of intracranial, saccular aneurysms with the Next Generation Neuroform Stent System. The study will evaluate the permanent morbidity and mortality rate within the 12 to 16 months following the procedure. The study will evaluate as well the percent occlusion of the treated target lesion on angiography in the absence of retreatment, or parent artery stenosis at the target location at 12 to 16 months. Subjects with documented saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling, provided they meet the other eligibility criteria.
Sponsor: Stryker Neurovascular

Current Primary Outcome:

  • permanent morbidity rate defined as any major ipsilateral stroke or neurolgocial death within 12 to 16 months following the procedure [ Time Frame: 16 Months ]
  • mortality rate within 12 to 16 months following the procedure [ Time Frame: 16 Months ]


Original Primary Outcome: morbidity and mortality rates defined as any major ipsilateral stroke or neurological death within 12 to 16 months following the procedure [ Time Frame: 16 Months ]

Current Secondary Outcome:

  • Complete aneurysm occlusion rate of the treated target lesion on 16 month imaging [ Time Frame: 16 months ]
    Measured by the Raymond Scale Class 1,2,3 with imaging at 12 to 16 months
  • New or worsening major ipsilateral stroke as measured by NIHSS and mRS [ Time Frame: 16 months ]
  • Subarachnoid hemorrhage rate [ Time Frame: 16 months ]
  • Aneurysm Rupture rate [ Time Frame: 16 months ]


Original Secondary Outcome:

  • Complete aneurysm occlusion of the treated target lesion on 16 month imaging [ Time Frame: 16 months ]
  • New or worsening major ipsilateral stroke as measured [ Time Frame: 16 months ]
  • Subarachnoid hemorrhage [ Time Frame: 16 months ]
  • Aneurysm Rupture [ Time Frame: 16 months ]


Information By: Stryker Neurovascular

Dates:
Date Received: May 23, 2016
Date Started: September 2016
Date Completion: February 2019
Last Updated: April 23, 2017
Last Verified: April 2017